Chronic Kidney Disease stage3NCT06037265
PR-0164 First in Human Clinical Trial of the PAVmed PortIO Intraosseous Infusion System
A study testing PAVmed PortIO™ Intraosseous Infusion System in people with Chronic Kidney Disease stage3 and Chronic Kidney Disease stage4, run by PAVmed Inc. at 4 sites in Colombia.
Trial summary
The PortIO is intended to provide non-emergent vascular access in chronic kidney disease (CKD) patients where preservation of venous anatomy is desired and iatrogenic damage to the veins should be avoided and/or patients with poor/difficult vascular access. Read more about this study
- Who is it for?
- Ages 22 to 99 years
- Conditions the study is for
- Chronic Kidney Disease stage3, Chronic Kidney Disease stage4, Chronic Kidney Disease Stage 5
- What is being tested?
- PAVmed PortIO™ Intraosseous Infusion System
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 4 sitesColombia
- Study dates
- 20 Jan 2022to 29 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet the following criteria are eligible for participation in the study:
- Subject is > 22 years old
- Subject has grade 3 or higher CKD and is receiving or may receive renal replacement therapy with hemodialysis OR has poor/difficult vascular access.
- Subject does NOT need urgent or emergent vascular access;
- Subject, or authorized representative, signs a written Informed Consent form to participate in the study, prior to any study mandated procedures
- Subject is willing and able to complete follow-up requirement
Who cannot join
- Subjects must be EXCLUDED from participation in this study if ANY of the following criteria are met:
- Fracture (within 6 months), bone tumor, or structural bone abnormality (such as osteogenesis imperfect, avascular necrosis, and severe osteoporosis) of the target bone
- Excessive overlying soft tissue, nerves, arteries, tendons or absence of anatomic landmarks at the target site
- Previous orthopedic procedure at or near the insertion site (e.g. artificial joint, rigid fixation hardware)
- IO access or attempted IO access in the target bone within 7 days
- Known or suspected allergy to any device component or materials contained in the device
Show all 16Show fewer
- Local tissue factors preventing proper device stabilization and / or access including local infection, fragile tissue and absence of adequate or excessive overlying soft tissue.
- Subject with known unstable cardiac disease (recent MI within 30 days, cardiac surgery within 6 months, unstable angina, severe aortic stenosis/regurgitation, severe congestive heart failure, severe mitral stenosis/regurgitation), uncontrolled diabetes (blood glucose >240 mg/dl) or subjects on immunosuppressive medications (e.g. organ transplant patients)
- Subjects who are anticipated to receive infusion of blood or blood products, chemotherapeutic agents, hypertonic solutions, caustic agents or any agents known to harm bone marrow or cause bone marrow suppression such as azathioprine, procainamide, sulfasalazine via the test device.
- Insertion into the humerus on the same side as a previous mastectomy
- Known allergy to contrast media or local anesthetics (e.g. lidocaine, bupivacaine)
- Subjects with known bleeding disorders including thrombocytopenia, thrombasthenia, hemophilia or Von Willebrand's disease.
- Subjects with a history of hypercoagulable disorders such as protein S or C deficiency, Factor 5 Leiden resistance, Antithrombin III deficiency, Antiphospholipid antibody syndrome, Heparin Induced Thrombocytopenia etc.
- Subjects who are anticipated to need power injections via the test device for CT scan or angiography
- Subject has other medical, social or psychological problem that in the opinion of the investigator precludes them from fully participating
- Women who are pregnant, women who are attempting to become pregnant, as well as women who are breast feeding.
Trial locations and contacts
4 sites in 1 country.
Colombia4 sites
Cediul
Barranquilla, Atlántico
Sabbag Radiologos
Barranquilla, Atlántico
Cirulaser Andes
Bogotá, Bogota D.C.
Centro Medico Imbanaco
Cali, Valle de Cauca
About this study
Official title: First in Human Clinical Trial of the PAVmed PortIO Intraosseous Infusion System to Evaluate Safety and Performance
The PortIO is intended to provide non-emergent vascular access in chronic kidney disease (CKD) patients where preservation of venous anatomy is desired and iatrogenic damage to the veins should be avoided and/or patients with poor/difficult vascular access. The PortIO device may be inserted into the proximal or distal tibia or the proximal humerus in adults, and provides up to 60 days of intraosseous vascular access for delivery of fluids and medications.
Read the detailed description
This is a prospective, open label, single arm, non-randomized, multicentric first in human clinical trial of the PortIO device for intraosseous infusion of fluids and/or medications for up to 60 days in subjects that meet the inclusion criteria. Both hospitalized patients as well as outpatients can be screened and, if appropriate, can be consented and enrolled into the study. They will have the PortIO device implanted by a qualified physician and then undergo prescribed infusions as needed and determined by the treating physician over either a 7-day or a 60-day period. The device will then be removed after the 7 days or 60 days of use and the subject followed up at 30 days after explant.
- Conditions
- Chronic Kidney Disease stage3, Chronic Kidney Disease stage4, Chronic Kidney Disease Stage 5, Poor Vascular Access
- Being tested
- PAVmed PortIO™ Intraosseous Infusion System
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAVmed PortIO™ Intraosseous Infusion SystemDevice
The PortIO is intended to provide non-emergent vascular access in chronic kidney disease (CKD) patients where preservation of venous anatomy is desired and iatrogenic damage to the veins should be avoided and/or patients with poor/difficult vascular access. The PortIO device may be inserted into the proximal or distal tibia or the proximal humerus in adults, and provides up to 60 days of intraosseous vascular access for delivery of fluids and medications.
| Study group | Role | What they receive |
|---|---|---|
| Total Sample Size | Other | The total sample size will be up to 40 subjects that complete the full intended implant durations of either 7 days (n=up to 10) or60 days (n=up to 30). Group 1 patients will be enrolled first and at least 5 patients will complete the 7-day implant duration before Group 2 patients begin enrollment. Group 1 and Group 2 subjects can be screened in parallel. Group 2 enrollment will start immediately after at least 5 subjects in Group 1 have successfully completed the 7-day implantation period. Study subjects will have the PortIO device implanted by a qualified physician (Table 5) and then undergo prescribed, standard of care infusion regimen as determined by their treating physician over either the 7-day or the 60-day period. After the intended implant duration and use during the implant period, the device will then be removed and the subject will be followed for safety at 30 days after explant. Receives: Device: PAVmed PortIO™ Intraosseous Infusion System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Performance
Incidence of successful implant in the target anatomic location; Patency through the implant duration, with final patency assessment performed immediately prior to device explant; Incidence of successful device explant
Measured: Entire duration of Study an average of 2 years
Primary Safety
Incidence of serious device-related adverse events
Measured: Entire duration of Study and average of 2 years
Secondary outcomes (1)
Secondary Endpoint
Incidence of all device-related adverse events, whether serious or non-serious
Measured: Entire duration of Study an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start20 Jan 2022
- Primary completion29 Jul 2024
- Study completion29 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease stage3Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- PAVmed Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gisella Lopez, Study director, Lucid Diagnostics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06037265
- Sponsor's protocol ID
- PR-0164
- Status last verified
- Jun 2025
- First submitted
- 29 Aug 2023
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First in Human Clinical Trial of the PAVmed PortIO Intraosseous Infusion System to Evaluate Safety and Performance
- ClinicalTrials.gov ID
- NCT06037265
- Acronym / sponsor ID
- PR-0164
- Conditions
- Chronic Kidney Disease stage3, Chronic Kidney Disease stage4, Chronic Kidney Disease Stage 5, Poor Vascular Access
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- PAVmed Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 29 Jul 2024 (actual)
- Study completion
- 29 Jul 2024 (actual)
- First posted
- 14 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The PortIO is intended to provide non-emergent vascular access in chronic kidney disease (CKD) patients where preservation of venous anatomy is desired and iatrogenic damage to the veins should be avoided and/or patients with poor/difficult vascular access. The PortIO device may be inserted into the proximal or distal tibia or the proximal humerus in adults, and provides up to 60 days of intraosseous vascular access for delivery of fluids and medications.
Detailed description
This is a prospective, open label, single arm, non-randomized, multicentric first in human clinical trial of the PortIO device for intraosseous infusion of fluids and/or medications for up to 60 days in subjects that meet the inclusion criteria. Both hospitalized patients as well as outpatients can be screened and, if appropriate, can be consented and enrolled into the study. They will have the PortIO device implanted by a qualified physician and then undergo prescribed infusions as needed and determined by the treating physician over either a 7-day or a 60-day period. The device will then be removed after the 7 days or 60 days of use and the subject followed up at 30 days after explant.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Total Sample Size | Other | Device: PAVmed PortIO™ Intraosseous Infusion SystemThe total sample size will be up to 40 subjects that complete the full intended implant durations of either 7 days (n=up to 10) or60 days (n=up to 30). Group 1 patients will be enrolled first and at least 5 patients will complete the 7-day implant duration before Group 2 patients begin enrollment. Group 1 and Group 2 subjects can be screened in parallel. Group 2 enrollment will start immediately after at least 5 subjects in Group 1 have successfully completed the 7-day implantation period. Study subjects will have the PortIO device implanted by a qualified physician (Table 5) and then undergo prescribed, standard of care infusion regimen as determined by their treating physician over either the 7-day or the 60-day period. After the intended implant duration and use during the implant period, the device will then be removed and the subject will be followed for safety at 30 days after explant. |
Who may qualify
- Ages
- 22 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects must meet the following criteria are eligible for participation in the study:
Key exclusion criteria (16 listed)
- Subjects must be EXCLUDED from participation in this study if ANY of the following criteria are met:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PAVmed PortIO™ Intraosseous Infusion SystemThe PortIO is intended to provide non-emergent vascular access in chronic kidney disease (CKD) patients where preservation of venous anatomy is desired and iatrogenic damage to the veins should be avoided and/or patients with poor/difficult vascular access. The PortIO device may be inserted into the proximal or distal tibia or the proximal humerus in adults, and provides up to 60 days of intraosseous vascular access for delivery of fluids and medications. | Device | Total Sample Size |
Primary outcome
Primary Performance
Time frame: Entire duration of Study an average of 2 years
Incidence of successful implant in the target anatomic location; Patency through the implant duration, with final patency assessment performed immediately prior to device explant; Incidence of successful device explant
Primary Safety
Time frame: Entire duration of Study and average of 2 years
Incidence of serious device-related adverse events
1 secondary outcome
Secondary Endpoint
Time frame: Entire duration of Study an average of 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gisella Lopez study director
Lucid Diagnostics
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PAVmed PortIO™ Intraosseous Infusion System in people with Chronic Kidney Disease stage3 and Chronic Kidney Disease stage4, run by PAVmed Inc. at 4 sites in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Performance (time frame: Entire duration of Study an average of 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2025.